This invention relates to a tamper evident unit dose package for packaging an individual drug dose. In particular, it relates to a tamper evident package that can be opened and used as a device for administering the contained drug without removing the drug from the package.
Unit dose packaging, developed in the 1960's, provides a system of drug distribution used primarily for hospitals and nursing homes. Drug doses are packaged individually and the packages are labeled to clearly identify the drug contained within the package Using a unit dose drug packaging system decreases the amount of time required to prepare individual drug doses for patients. The system, when properly implemented, also reduces the chance of administering the wrong drug, or wrong dosage of the drug to the patient. Therefore, unit dose drug distribution systems and their variations are employed in many hospitals and nursing homes in the United States.
Unfortunately, those who administer unit dose packaged drugs do not always follow the prescribe guidelines for implementing the system. It is a common practice to prepare several patients' drug orders at one time. The preparer removes the drug dose from the unit dose package and places it in a souffle cup, which contains other drug doses for the same patient. Then, the prepared souffle cup of drug doses is presented to the patient and the contents emptied into his mouth. Subsequently, juice or water is given with instructions for the patient to swallow the doses. This procedure makes it difficult for the doses to be comfortably swallowed.
Mixing different drug doses within a souffle cup also increases the risk of administering an improper dosage to the patient. Care is taken to ensure that the correct cup is given to the right patient, but once the doses are mixed together, only experienced medical professionals, for example pharmacists, are able to positively identify and confirm that the correct drugs and dosages are contained within the cup. Checking the patient's drug order before it is ingested is important in practice, particularly in nursing homes where a variety of drugs are administered every day to different patients. In fact, the unit dose packaging system was developed to ensure that the correct drug dose is administered to the right patient. It was not envisioned that the medical professionals administering the unit dose package system would remove the doses from their packages and mix them together in a manner in direct conflict with the way the system was designed to be implemented.
An alternative method of administering the unit dose packaged drugs that avoids the difficult swallowing step encountered in the souffle cup method involves removing the dose from the package and crushing it into a powder form. The powdered drug is then mixed with the patient's food, so that it may be eaten rather than swallowed with a liquid. Apart from the bad taste experienced by eating such a mixture, this practice introduces an error in administering an accurate quantity of the drug. Crushing the drug into powder form also involves an additional step in preparing the drug for ingestion by the patient, which increases the amount of time needed to administer the drug.
In view of the practices of administering unit dose packaged drugs, it is apparent that several problems exist with the current system. Removing the doses from the package creates uncertainties in later identifying the drug after it has ben unpackaged. Mixing several doses together in a souffle cup makes it difficult for the patient to swallow the doses. Further, to alleviate the swallowing problem, the practice of crushing the dose to powder form creates possible inaccuracies in administering the correct dosage to the patient in addition to increasing the amount of time spent per patient in administering the drug. Therefore, a need exists for a unit dose package that can be used in a packaging and distribution system that when implemented eliminates the need for the above practices.
The pharmaceutical industry, is currently faced with an even greater problem. Several widely publicized incidents of random drug package tampering have led to the tragic deaths of innocent victims, who have unknowingly ingested drugs that have been tampered with. Up to this point, packages had been designed with little regard for warning the consumer that the contents of the package have been tampered with. In response to drug tampering incidents, tamper evident packages have been utilized in the industry to offer more protection for the consumer by providing a package having a safety seal or the like that if broken indicates the package may have been tampered with.
Even though a system of tamper evident packaging has been implemented, some types of drug forms, such as capsules, have still been tampered with. It is very difficult to determine if an individual capsule has been opened and a contaminate placed within the capsule. As a result, it has been proposed that a seal be applied to each individual capsule so that the consumer is able to determine if the individual capsule has been tampered with by examining the seal. If the seal is in place then the drug dose has not been tampered with. Providing individual seals for each capsule is expensive and involves retooling the capsule manufacturing machinery. Absent the implementation of effective protective measures, however, the pharmaceutical industry may be faced with a large group of consumers unwilling to purchase drugs that are packaged in capsule form. Therefore, if the pharmaceutical industry does not react to protect the consumer with improved drug packaging, the market for some drug forms particularly capsules, will diminish. A practical design for tamper evident drug packaging, particularly for capsules, needs to be developed. Preferably, this design should provide a package that can be produced at a minimum of cost, since any additional costs will be passed onto the consumer.
The tampering that has occurred to date has involved over-the-counter packaged drugs. A drug dose is removed from the package, tampered with, and replaced within the package in its tampered form. The consumer then, not noticing any evidence that the package has been tampered with, ingests the medication. In the use of over-the-counter drugs, the drug is removed from the package and immediately ingested. However in hospitals and nursing homes, the drug doses are removed from the packages usually at a nursing station, and later administered to the patient. Presently, tampering in hospitals and nursing homes is not a problem, but once the drug dose is removed from the package, the dose is subject to possible tampering. Therefore, the medical professionals in hospitals and nursing homes are confronted with the possibility of someone tampering with the drug dose after it has been unpackaged and before it has been administered.
Several attempts have been made to solve the above mentioned problems. For example, to alleviate the problems of administering drug doses, a pill douser is disclosed in U.S. Pat. No. 2,436,505 that includes a bowl and tube extending downwardly from the bowl that is intended to be placed in a quantity of liquid. The bowl supports a pill or tablet. In use the mouth is engaged about the periphery of the bowl for drawing a liquid through the tube and into the user's mouth with the pill or tablet. The douser, however, is not used for packaging the drug, and the drug dose must still be transferred from the package to the douser with the resultant possibility that the dose may be tampered with in the interim.